BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT PSL HA CLUSTER 54MM

    MDR report key: 2182122 · Received June 23, 2011

    Report

    Report Number
    9616680-2011-00412
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING THE THA, THE SURGEON COMBINED THE TRIDENT INSERT INTO THE TRIDENT PSL HA CLUSTER SHELL. HOWEVER, IT WAS VERY DIFFICULT FOR HIM. HE THOUGHT THAT THE SHELL WAS DEFORMED DUE TO A IMPACTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA CLUSTER 54MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 34583302

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other